The time has come: the official compromise (draft) text for the upcoming Machinery Regulation (“Draft Machinery Regulation”) is available, please download the file. The text, which reflects the compromises reached on December 15, 2022, is of utmost relevance to all companies that deal with machinery; e.g. manufacture, import, distribute or operate machinery.
Regarding its content, the present draft is most likely the almost final document. After all, it is the result of the long (approx. 8 months!) trialogue negotiations between the European Commission, the European Parliament and the European Council. There will probably still be editorial changes, e.g. the articles with letters (e.g. Article 4a, 10a, 12a) will most likely disappear and receive their own article number. Overall, however, machinery related business will have to deal with the requirements set up therein in the coming years. The Machinery Regulation is the heart of machinery law – without compliance with this regulation, (machinery) sales and (machinery) operation are prohibited.
The final Machinery Regulation will be of utmost importance for all "Stakeholders" in the field of products that fall under its – conceivably broad – scope, see, for example, the definition of machinery in Article 3 para. 1 Draft Machinery Regulation, but also the products "related" to machinery to which the Machinery Regulation will be applicable, Article 2 para. 1 Draft Machinery Regulation. On the one hand, the law on machinery is notably reaching its current peak: from the present 30 recitals and 29 articles, machinery law has swelled to 87 recitals and 52 articles. On the other hand, many of the particularly intensive changes to the machinery law foreseen in the first draft of 21 April 2021 (COM(2021) 202 final) have been removed from the Draft Machinery Regulation. This includes, for example, the additional mandatory requirement of a notified body for many of the products previously designated as "high-risk machinery products" (this term has also been dropped). The Draft Machinery Regulation thus breaks new ground, but the big revolution has failed to materialise.
According to Article 52 of the Draft Machinery Regulation, a large part of the new Machinery Regulation will be applicable 42 months and 20 days after publication in the Official Journal of the European Union. From that point on, machinery and other products covered by the Machinery Regulation may in principle only be made available on the market if they comply with the (new) requirements of the Machinery Regulation, Article 50 para. 1 Draft Machinery Regulation.
The following is a brief – but not conclusive – overview of some of the issues that have recently been the subject of further debate:
- No "high-risk machinery products" – Graduated risk classes
On the one hand, the "special" category of machinery known from Annex IV of the EC Machinery Directive 2006/42/EC remains. On the other hand, Annex I is now divided into Parts A and B. Whereas initially the participation of a notified body was mandatory for all products listed in Annex I, the list has now been shrunk. The following products remain in Annex I Part A, for whose conformity assessment the Draft Machinery Regulation requires a notified body (cf. Article 21 para. 2 Draft Machinery Regulation, together with the references to the conformity assessment procedures):
(i) “removable mechanical power transmission devices including their guards,”
(ii) “Guards for removable mechanical power transmission devices,”
(iii) “Vehicle lifting platforms,”
(iv) “Portable cartridge-operated fixing and other impact machinery,”
(v) “Safety components with fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions” and
(vi) "Machinery embedding systems with fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions that have not been placed independently on the market, in respect only to those systems."
Nothing has remained of the term "high-risk machinery products" envisaged in the original draft. Even the name "potentially high-risk machinery products" envisaged in the version proposed by the committees of the European Parliament has been dropped. Only in the recitals (e.g. 46b, 50) there are still considerations to this effect: "machinery or related products that have a higher risk factor, a stricter conformity assessment procedure requiring the participation of a notified body should be required."
With regard to the products in Annex I Part B, the so-called "internal production control" is also provided for as a conformity assessment procedure - a procedure that the manufacturer can complete without the involvement of a "third party". In Part B of Annex I, many of the machines listed in Annex IV of the EC Machinery Directive have moved over.
According to the compromise version, EU Commission option to include or delete products in / from Annex I by means of delegated acts remains unchanged. A new feature will be the right of stakeholders to be consulted before a machine is included in Annex I, cf. recital 65 and Article 5 para. 2 of the Machinery Regulation.
- “Artificial intelligence" – link removed
It had already become apparent: The link between the Machinery Regulation and the European Proposal for a Regulation on Artificial Intelligence ("Draft AI Act”) has been dropped. This is unfortunate because there was also a breakthrough for the Draft AI Act during the trialogue negotiations and the adoption of the regulation is within reach. It remains to be seen to what extent the "AI component" of the Draft Machinery Regulation will now go hand in hand with the Draft AI Act.
- Technical standardization by the EU Commission – merely a fall-back position
Technical standardization by the EU Commission, which was still envisaged in the draft of the Machinery Regulation, has been restricted in the compromise version - which is to be welcomed.
According to the Draft Machinery Regulation, the EU Commission is only to be allowed to carry out technical standardization itself by issuing technical specifications under strict conditions (which must be met cumulatively):
(i) the EU Commission must have issued a standardization mandate to at least one European standards organization,
(ii) the standardization organization (a) has rejected the standardization request, (b) does not deliver within the deadline set by the EU Commission, or (c) has developed a standard that does not comply with the standardization request, and
(iii) an alternative harmonized standard does not exist and is not expected to be published in the Official Journal of the European Union within a reasonable time.
The soon to be finalised Machinery Regulation regulates the future of machine construction and machine distribution in a new and EU-wide uniform way – we will stay tuned and keep you up to date!